Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia
This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia...
Brief Summary
Official Title: “A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Trial to Determine the Lipid-Lowering Efficacy and Safety of BMS-298585 Alone or in Combination With Pravastatin in Subjects With Mixed Dyslipidemia”
This is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of BMS-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Muraglitazar
Outcome Measures for this Clinical Trial
Primary Measures
- To compare at a .05 level of significance, after 6 weeks of oral administration of double-blind treatment the percent change from baseline to average triglycerides (TG), week 5-6 between 5, 10 and 20 mg
Secondary Measures
- Percent changes from baseline to average at week 5-6 of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, apolipoprotein A1 (ApoA1), and free fatty acid (FFA) levels
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Non-diabetics
- Serum TG >150 mg/dL and < or = 600 mg/dL
- Serum LDL-C >130 mg/dL
Exclusion Criteria:
- Type 1 or type 2 diabetics
- Fasting plasma glucose >126 mg/dL
- Treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (Week 2):
- Niacin or bile-acid binding agents and HMG CoA reductase inhibitors: 8 weeks
- Fibrates: 8 weeks
- Probucol: 1 year
- History of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bristol-Myers Squibb Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00245388
Study ID Number: CV168-008
ClinicalTrials.gov Identifier: NCT00245388
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00245388
